Trial Outcomes & Findings for QBSAfe: A Novel Approach to Diabetes Management Focused on Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events (NCT NCT04514523)
NCT ID: NCT04514523
Last Updated: 2023-01-06
Results Overview
Patient responses to post-visit questionnaires.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
Baseline [Post Clinical Encounter]
Results posted on
2023-01-06
Participant Flow
84 participants and 7 clinicians
Participant milestones
| Measure |
Single-Arm Intervention Group - Patients
QBSAfe Toolkit: The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.
|
Single-Arm Intervention Group - Clinicians
Clinicians who participated in the study
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
7
|
|
Overall Study
Completed Video or Audio
|
68
|
7
|
|
Overall Study
Completed Post Visit Questionnaire
|
58
|
7
|
|
Overall Study
COMPLETED
|
58
|
7
|
|
Overall Study
NOT COMPLETED
|
26
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline characteristics were not collected for clinicians
Baseline characteristics by cohort
| Measure |
Implementation Arm
n=84 Participants
QBSAfe Toolkit: The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.
|
Clinicians
n=7 Participants
Clinicians who participated in the study
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
0 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
39 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
|
Age, Categorical
>=65 years
|
45 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
45 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
|
Age, Continuous
|
74.4 years
STANDARD_DEVIATION 15.4 • n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
74.4 years
STANDARD_DEVIATION 15.4 • n=84 Participants • Baseline characteristics were not collected for clinicians
|
|
Sex: Female, Male
Female
|
39 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
39 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
|
Sex: Female, Male
Male
|
45 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
45 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
0 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
0 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
0 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
14 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
|
Race (NIH/OMB)
White
|
66 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
66 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
0 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
4 Participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
|
Region of Enrollment
United States
|
84 participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
—
|
84 participants
n=84 Participants • Baseline characteristics were not collected for clinicians
|
PRIMARY outcome
Timeframe: Baseline [Post Clinical Encounter]Population: Patients who had their visit recorded and answered post visit questionnaires
Patient responses to post-visit questionnaires.
Outcome measures
| Measure |
Single-Arm Intervention Group
n=58 Participants
QBSAfe Toolkit: The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.
|
Single-Arm Intervention Group - Clinicians
Clinicians who participated in the study
|
|---|---|---|
|
Acceptability - Patients
These cards helped me talk about my situation during my visit · Strongly Agree
|
16 Participants
|
—
|
|
Acceptability - Patients
These cards helped me talk about my situation during my visit · Agree
|
21 Participants
|
—
|
|
Acceptability - Patients
These cards helped me talk about my situation during my visit · Neutral
|
12 Participants
|
—
|
|
Acceptability - Patients
These cards helped me talk about my situation during my visit · Disagree
|
6 Participants
|
—
|
|
Acceptability - Patients
These cards helped me talk about my situation during my visit · Strongly Disagree
|
3 Participants
|
—
|
|
Acceptability - Patients
I would like to have these cards available to me at my next visit · Strongly Agree
|
12 Participants
|
—
|
|
Acceptability - Patients
I would like to have these cards available to me at my next visit · Agree
|
10 Participants
|
—
|
|
Acceptability - Patients
I would like to have these cards available to me at my next visit · Neutral
|
21 Participants
|
—
|
|
Acceptability - Patients
I would like to have these cards available to me at my next visit · Disagree
|
12 Participants
|
—
|
|
Acceptability - Patients
I would like to have these cards available to me at my next visit · Strongly Disagree
|
3 Participants
|
—
|
|
Acceptability - Patients
I believe other patients like me would benefit from these cards · Strongly Agree
|
19 Participants
|
—
|
|
Acceptability - Patients
I believe other patients like me would benefit from these cards · Agree
|
26 Participants
|
—
|
|
Acceptability - Patients
I believe other patients like me would benefit from these cards · Neutral
|
9 Participants
|
—
|
|
Acceptability - Patients
I believe other patients like me would benefit from these cards · Disagree
|
3 Participants
|
—
|
|
Acceptability - Patients
I believe other patients like me would benefit from these cards · Strongly Disagree
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline [Post Clinical Encounter]Population: Questionnaires completed by clinicians after each patient encounter
Clinician responses to post-visit questionnaires.
Outcome measures
| Measure |
Single-Arm Intervention Group
n=69 Questionnaires after each encounter
QBSAfe Toolkit: The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.
|
Single-Arm Intervention Group - Clinicians
Clinicians who participated in the study
|
|---|---|---|
|
Acceptability - Clinicians
I felt confident in responding to issues raised by the patient · Strongly Agree
|
48 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I felt confident in responding to issues raised by the patient · Agree
|
14 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I felt confident in responding to issues raised by the patient · Neutral
|
4 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I felt confident in responding to issues raised by the patient · Disagree
|
3 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I felt confident in responding to issues raised by the patient · Strongly Disagree
|
0 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I would like to use these cards with a patient like this next time · Strongly Agree
|
43 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I would like to use these cards with a patient like this next time · Agree
|
11 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I would like to use these cards with a patient like this next time · Neutral
|
14 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I would like to use these cards with a patient like this next time · Disagree
|
1 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I would like to use these cards with a patient like this next time · Strongly Disagree
|
0 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I would recommend these cards to my colleagues · Strongly Agree
|
46 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I would recommend these cards to my colleagues · Agree
|
10 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I would recommend these cards to my colleagues · Neutral
|
11 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I would recommend these cards to my colleagues · Disagree
|
1 Questionnaires after each encounter
|
—
|
|
Acceptability - Clinicians
I would recommend these cards to my colleagues · Strongly Disagree
|
0 Questionnaires after each encounter
|
—
|
SECONDARY outcome
Timeframe: Baseline [Post Clinical Encounter]Population: Number of patients and number of clinicians in the study
Percentage of participants who completed the study procedures.
Outcome measures
| Measure |
Single-Arm Intervention Group
n=84 Participants
QBSAfe Toolkit: The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.
|
Single-Arm Intervention Group - Clinicians
n=7 Participants
Clinicians who participated in the study
|
|---|---|---|
|
Feasibility 1
|
58 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline [Post Clinical Encounter]Percentage of recorded visits in which the QBSAFE toolkit was used assessed by Number of visits QBSAFE was used/Number of recorded visits.
Outcome measures
| Measure |
Single-Arm Intervention Group
n=58 Participants
QBSAfe Toolkit: The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.
|
Single-Arm Intervention Group - Clinicians
Clinicians who participated in the study
|
|---|---|---|
|
Feasibility 2
|
58 percentage of visits QBSAFE was used
|
—
|
SECONDARY outcome
Timeframe: Baseline [Post Clinical Encounter]Population: Number of recruited patients
Time to recruit 84 subjects across 3 sites.
Outcome measures
| Measure |
Single-Arm Intervention Group
n=84 Participants
QBSAfe Toolkit: The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.
|
Single-Arm Intervention Group - Clinicians
Clinicians who participated in the study
|
|---|---|---|
|
Feasibility 3
|
145 Days
|
—
|
Adverse Events
Single-Arm Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place